Quality Specialist III

Thermo Fisher Scientific•Greenville, NC

2d•Onsite

About The Position

COMPANY INFORMATION Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our global organization of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com . GROUP/DIVISION SUMMARY The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization. POSITION SUMMARY In this position, you’ll drive quality execution across sterile operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for both commercial and product development services products. Additionally, this position will provide quality guidance and expertise for implementation of practical process improvements and continuous improvement initiatives. This is a quality on the floor position. Hours 6:00am-6:00pm on a 2/2/3 rotating schedule.

Requirements

High School Diploma or equivalent required with 4 years experience
Bachelor’s degree, preferred with 2 years relevant experience
Experience with previous experience in Quality Assurance, or Quality Control or Operations/Manufacturing.
Previous experience in pharmaceutical industry; preferably aseptic or sterile processes strongly preferred, experience in other regulated environments may be considered (i.e. ISO 9001).
Ability to capture data, analyze & troubleshoot process issues & equipment problems cross-fuctionally with production employees.
Ability to lead, support & empower team/peers.
Must be legally authorized to work in the United States now or in the future without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.

Nice To Haves

Professional certifications (ex: CQA) and training (Six Sigma) are a plus.

Responsibilities

Perform daily quality assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies, assure quality, and compliance per site procedures and cGMPs.
Daily interaction with employees to assist with troubleshooting, documentation corrections/notes, and guidance with aseptic technique.
Champions quality culture by aiding personnel in understanding application of policies and controls.
Participates in RAPID event response and provides quality guidance for deviation events.
Advances deviation events to the appropriate area and quality management.
Performs quality review and approval of procedures, training documents, and forms of moderate to high complexity.
Performs quality review of deviations and change controls of moderate to high complexity in support of job function.
Participates as the quality assurance representative in Root Cause Analysis to support deviation investigations of moderate to high complexity.
Performs quality batch record in-line (during production activities) review.
Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives.